Likferr 100 solution for intravenous administration 20 mg/ml 5 ml 5 pcs. in Moscow

LIKFERR100

Directions for use and doses

Introduction
Likferr100 is administered only intravenously - slowly in a stream or drip, as well as into the venous section of the dialysis system and is not intended for intramuscular administration. Simultaneous administration of the full (cumulative) therapeutic dose of the drug is unacceptable

Before administering the first therapeutic dose, it is necessary to prescribe a test dose. If during the observation period phenomena of intolerance occur, administration of the drug should be stopped immediately. Before opening, the ampoule must be inspected for possible sediment and damage. Only brown solution without sediment can be used.

Drip administration

It is preferable to administer Likferr100 by drip infusion in order to reduce the risk of a pronounced decrease in blood pressure (BP) and the risk of the solution entering the perivenous space. Immediately before infusion, Likferr 100 should be diluted 0.9 %

sodium chloride solution in a ratio of 1:20 [for example, 1 ml (20 mg of iron) in 20 ml of 0.9% sodium chloride solution]. The resulting solution is administered at the following speed: 100 mg of iron - in no less than 15 minutes; 200 mg of iron - within 30 minutes; 300 mg of iron - within 1.5 hours; 400 mg of iron - within 2.5 hours; 500 mg of iron - within 3.5 hours. The maximum tolerated single dose of 7 mg iron/kg body weight should be administered over a minimum of 3.5 hours, regardless of the total dose of the drug.

Before the first drip administration of a therapeutic dose of Likferr100, it is necessary to administer a test dose: 1 ml of Likferr100 (20 mg iron) for adults and children weighing more than 14 kg, and half the daily dose (1.5 mg iron/kg) for children with body weight less than 14 kg for 15 minutes. In the absence of adverse events, the remainder of the solution should be administered at the recommended rate.

Jet injection

Likferr100 can also be administered as an undiluted solution intravenously slowly, at a rate of 1 ml of Likferr100 (20 mg iron) per minute (for example, 5 ml of Likferr100 (100 mg iron) is administered over 5 minutes). The maximum volume of the drug should not exceed 10 ml of Likferr 100 (200 mg of iron) per injection.

After the injection, the patient is recommended to fix his arm in an extended position for a while.

Before the first jet injection of a therapeutic dose of Likferr100, a test dose should be administered: 1 ml of Likferr100 (20 mg iron) for adults and children weighing more than 14 kg, and half the daily dose (1.5 mg iron/kg) for children with body weight less than 14 kg for 1-2 minutes. If there are no adverse events during the next 15 minutes of observation, the remainder of the solution should be administered at the recommended rate. After the injection, the patient is recommended to fix his arm in an extended position.

Introduction to Dialysis System

Likferr100 can be administered directly into the venous portion of the dialysis system, strictly following the rules described for intravenous injection.

Dose calculation

Before administration, it is necessary to individually calculate the total iron deficiency in the body using the following formula:

Total iron deficiency (mg)

= body weight (kg) x (normal Hb - patient’s Hb (g/l)) x 0.24 + deposited iron (mg)

For patients weighing less than 35 kg:

— amount of deposited iron = 15 mg/kg body weight,

- normal Hb = 130 g/l.

For patients weighing more than 35 kg:

— amount of deposited iron = 500 mg,

- normal Hb = 150 g/l.

Coefficient 0.24 = 0.0034 x 0.07 x 1000 (iron content in hemoglobin = 0.34%; blood volume = 7 %

from body weight; coefficient 1000 = conversion from “g” to “mg”).

Then you should calculate the cumulative (course) dose of the drug Likferr100, which will need to be administered to replenish iron deficiency in the body according to the following formula:

Total volume of the drug (in ml)

= Total iron deficiency (mg)/ 20 mg/ml Approximate values ​​for total iron deficiency and the total volume of the drug to be administered during the course of therapy are given in the table:

The total volume of Likferr100 for treatment

The frequency of administration is determined by the doctor, but not more often than every other day.

Adults, including elderly (over 65 years old) patients:

5-10 ml Likferr100 (100 - 200 mg iron) 1-3 times a week.

Children:

There is only limited data on the use of the drug in children. If necessary, it is recommended to administer no more than 0.15 ml of Likferr 100 (3 mg of iron) per kg of body weight 1-3 times a week, depending on the Hb level.

Maximum tolerated single dose (adults, including elderly (over 65 years of age) patients):

For jet injection:

10 ml of the drug Likferr100 (200 mg of iron), duration of administration of at least 10 minutes.

For drip administration:

depending on the indications, a single dose can reach 500 mg of iron. The maximum permissible single dose is 7 mg of iron per kg of body weight and is administered once a week, but it should not exceed 500 mg of iron.

In general, larger doses are associated with a higher incidence of adverse events.

In cases where the total therapeutic dose exceeds the maximum permissible single dose, split administration of the drug is recommended.

If 1-2 weeks after the start of treatment with Likferr100 there is no improvement in hematological parameters, it is necessary to reconsider the initial diagnosis.

Dose calculation for replenishing iron after blood loss or autologous blood donation:

The dose of Likferr100 required to compensate for iron deficiency is calculated using the following formula:

If the amount of blood lost is known:

intravenous administration of 200 mg of iron (= 10 ml of the drug Likferr100) leads to the same increase in Hb concentration as the transfusion of 1 unit of blood (= 400 ml with an Hb concentration of 150 g/l).

Amount of iron that needs to be replaced (mg) = number of units of blood lost x 200 or

required volume of Likferr 100 (ml) = number of units of lost blood x 10.

—
Hb content decreases :
use the previous formula, provided that the iron depot does not need to be replenished.

The amount of iron that needs to be replenished [mg] = body weight [kg] x 0.24 x (normal Hb - patient’s Hb) (g/l),

For example: body weight 60 kg, Hb deficiency = 10 g/l - required amount of iron 150 mg, required volume of Likferr100 = 7.5 ml

Treatment of patients with chronic renal diseases on hemodialysis and receiving additional treatment with erythropoietin.

The drug is administered strictly intravenously. The injection itself should be carried out as slowly as possible, the duration of administration increases as the dose increases. The procedure is not particularly difficult for hemodialysis patients, as they usually have adequate intravenous access. The drug is administered in 0.9% sodium chloride solution for at least 15 minutes during the last 2 hours of the hemodialysis session.

Absolute iron deficiency (anemia correction phase):

- 30-50 mg iron/dialysis session or

- 1000 mg of iron for 6-10 weeks.

Maintenance phase

Various doses are prescribed in different modes:

— 10-25 mg iron/dialysis session or

- 100 mg of iron / once a month (depending on serum ferritin concentration).

Hemoglobin correction phase

- 150 mg of iron to increase concentration by 10 g/l.

Likferr 100® (Likferr 100®)

Introduction

Likferr100 is administered only intravenously - slowly in a stream or drip, as well as into the venous section of the dialysis system and is not intended for intramuscular administration. Simultaneous administration of the full (cumulative) therapeutic dose of the drug is unacceptable

Before administering the first therapeutic dose, it is necessary to prescribe a test dose. If during the observation period phenomena of intolerance occur, administration of the drug should be stopped immediately. Before opening, the ampoule must be inspected for possible sediment and damage. Only brown solution without sediment can be used.

Drip administration

It is preferable to administer Likferr100 by drip infusion in order to reduce the risk of a pronounced decrease in blood pressure (BP) and the risk of the solution entering the perivenous space. Immediately before infusion, Likferr 100 should be diluted with 0.9% sodium chloride solution in a ratio of 1:20 [for example, 1 ml (20 mg of iron) in 20 ml of 0.9% sodium chloride solution]. The resulting solution is administered at the following speed: 100 mg of iron - in no less than 15 minutes; 200 mg of iron - within 30 minutes; 300 mg of iron - within 1.5 hours; 400 mg of iron - within 2.5 hours; 500 mg of iron - within 3.5 hours. The maximum tolerated single dose of 7 mg iron/kg body weight should be administered over a minimum of 3.5 hours, regardless of the total dose of the drug.

Before the first drip administration of a therapeutic dose of Likferr100, it is necessary to administer a test dose: 1 ml of Likferr100 (20 mg iron) for adults and children weighing more than 14 kg, and half the daily dose (1.5 mg iron/kg) for children with body weight less than 14 kg for 15 minutes. In the absence of adverse events, the remainder of the solution should be administered at the recommended rate.

Jet injection

Likferr100 can also be administered as an undiluted solution intravenously slowly, at a rate of 1 ml of Likferr100 (20 mg iron) per minute (for example, 5 ml of Likferr100 (100 mg iron) is administered over 5 minutes). The maximum volume of the drug should not exceed 10 ml of Likferr 100 (200 mg of iron) per injection.

After the injection, the patient is recommended to fix his arm in an extended position for a while.

Before the first jet injection of a therapeutic dose of Likferr100, a test dose should be administered: 1 ml of Likferr100 (20 mg iron) for adults and children weighing more than 14 kg, and half the daily dose (1.5 mg iron/kg) for children with body weight less than 14 kg for 1-2 minutes. If there are no adverse events during the next 15 minutes of observation, the remainder of the solution should be administered at the recommended rate. After the injection, the patient is recommended to fix his arm in an extended position.

Introduction to Dialysis System

Likferr100 can be administered directly into the venous portion of the dialysis system, strictly following the rules described for intravenous injection.

Dose calculation

Before administration, it is necessary to individually calculate the total iron deficiency in the body using the following formula:

General iron deficiency (mg) = body weight (kg) x (normal Hb - patient’s Hb (g/l)) x 0.24 + deposited iron (mg)

For patients weighing less than 35 kg:

— amount of deposited iron = 15 mg/kg body weight,

- normal Hb = 130 g/l.

For patients weighing more than 35 kg:

— amount of deposited iron = 500 mg,

- normal Hb = 150 g/l.

Coefficient 0.24 = 0.0034 x 0.07 x 1000 (iron content in hemoglobin = 0.34%; blood volume = 7% of body weight; coefficient 1000 = conversion from “g” to “mg”).

Then you should calculate the cumulative (course) dose of the drug Likferr100, which will need to be administered to replenish iron deficiency in the body according to the following formula:

Total volume of the drug (in ml) = Total iron deficiency (mg) / 20 mg/ml Approximate values ​​of the total iron deficiency and the total volume of the drug for administration during the course of therapy are given in the table:

The total volume of Likferr100 for treatment

The frequency of administration is determined by the doctor, but not more often than every other day.

Adults, including elderly (over 65 years old) patients: 5-10 ml Likferr 100 (100 - 200 mg iron) 1-3 times a week.

Children: There are only limited data on the use of the drug in children. If necessary, it is recommended to administer no more than 0.15 ml of Likferr 100 (3 mg of iron) per kg of body weight 1-3 times a week, depending on the Hb level.

Maximum tolerated single dose (adults, including elderly (over 65 years of age) patients):

For jet administration: 10 ml of Likferr100 (200 mg of iron), duration of administration of at least 10 minutes.

For drip administration: depending on the indications, a single dose can reach 500 mg of iron. The maximum permissible single dose is 7 mg of iron per kg of body weight and is administered once a week, but it should not exceed 500 mg of iron.

In general, larger doses are associated with a higher incidence of adverse events.

In cases where the total therapeutic dose exceeds the maximum permissible single dose, split administration of the drug is recommended.

If 1-2 weeks after the start of treatment with Likferr100 there is no improvement in hematological parameters, it is necessary to reconsider the initial diagnosis.

Dose calculation for replenishing iron after blood loss or autologous blood donation:

The dose of Likferr100 required to compensate for iron deficiency is calculated using the following formula:

If the amount of blood lost is known: intravenous administration of 200 mg of iron (= 10 ml of Likferr 100) leads to the same increase in Hb concentration as a transfusion of 1 unit of blood (= 400 ml with an Hb concentration of 150 g/l).

The amount of iron that needs to be replenished (mg) = the number of units of blood lost x 200 or the required volume of Likferr 100 (ml) = the number of units of blood lost x 10.

— If the Hb content decreases: use the previous formula, provided that the iron depot does not need to be replenished.

The amount of iron that needs to be replenished [mg] = body weight [kg] x 0.24 x (normal Hb - patient’s Hb) (g/l),

For example: body weight 60 kg, Hb deficiency = 10 g/l - required amount of iron 150 mg, required volume of Likferr100 = 7.5 ml

Treatment of patients with chronic renal diseases on hemodialysis and receiving additional treatment with erythropoietin.

The drug is administered strictly intravenously. The injection itself should be carried out as slowly as possible, the duration of administration increases as the dose increases. The procedure is not particularly difficult for hemodialysis patients, as they usually have adequate intravenous access. The drug is administered in 0.9% sodium chloride solution for at least 15 minutes during the last 2 hours of the hemodialysis session.

Absolute iron deficiency (anemia correction phase):

- 30-50 mg iron/dialysis session or

- 1000 mg of iron for 6-10 weeks.

Maintenance phase

Various doses are prescribed in different modes:

— 10-25 mg iron/dialysis session or

- 100 mg of iron / once a month (depending on serum ferritin concentration).

Hemoglobin correction phase

- 150 mg of iron to increase concentration by 10 g/l.